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The INTERA Family magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The INTERA Family is the successor of the current (Gyroscan / NT INTERA family. It consists of various configurations with magnetic field strengths ( 0.5T, 1.0T, 1.5T & 3.0T) and different optional gradient types. The INTERA Family is based on the same platform with the same functionalities as its predecessor. The main differences with the its predecessors (predicate devices) are: Added new functionality: DIFFUSION TENSOR imaging differentiates tissues with restricted diffusion from tissues with normal diffusion. Operating software platform Microsoft Windows (instead of VMS) running . on the appropriate host-computer. Enhancements related to the use of up to date computer technology such as . larger electronic data storage (memory) capacity.

The provided text is a 510(k) summary for the Philips Medical Systems INTERA Family. It describes the device, its predicate, and its intended use. However, it does not include detailed information on acceptance criteria for a study, nor does it describe a study specifically designed to prove the device meets acceptance criteria as would be expected for a novel device.

The core of this submission is a claim of substantial equivalence to a previously cleared predicate device (Gyroscan / NT INTERA family). The document states:

• "The INTERA Family does not induce any other risks than already indicated for the predicate devices. It has the same safety and effectiveness as its predecessor."
• "It is the opinion of Philips Medical Systems that the Philips INTERA Family is substantially equivalent to its predecessor."

Therefore, the "acceptance criteria" and "study" described in the provided text are based on the premise of substantial equivalence, rather than a de novo study with specific performance metrics.

Here's an attempt to answer your questions based on the provided text, acknowledging the limitations regarding a formal "study":

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a traditional "test set" or a study involving patient data with a specific sample size. The claim of substantial equivalence relies on:

• The INTERA Family being "based on the same platform with the same functionalities as its predecessor."
• The new functionalities (like DIFFUSION TENSOR imaging) or software updates (Microsoft Windows) not introducing new safety or effectiveness concerns.

Therefore, there is no explicit 'sample size' or 'data provenance' for a test set mentioned, as the equivalence is based on engineering and functional comparison to the predicate, which would have undergone its own clearance process previously.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No "test set" and corresponding "ground truth" establishment by experts for this specific 510(k) submission is described. The reliance is on the general understanding and established safety/efficacy of the predicate device family.

4. Adjudication Method for the Test Set

Not applicable. As no test set analysis involving expert readers is described, no adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The INTERA Family is a Magnetic Resonance Diagnostic Device (MRDD), not an AI or CAD (Computer-Aided Detection/Diagnosis) device which would typically be assessed with MRMC studies comparing human readers with and without AI assistance. The submission describes hardware/software updates to an MR imager.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It's a medical imager.

7. The Type of Ground Truth Used

Not applicable. For a substantial equivalence claim based on an existing imaging platform with minor updates, a specific "ground truth" derived from patient outcomes or pathology for this new submission is not typically required or described. The assumption is that the imaging capability, like its predicate, provides images that "when interpreted by a trained physician, yield information that may assist in diagnosis."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. The "training" for such an MR system would refer to its engineering development and calibration, not a dataset for machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

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